Rosiglitazone (marketed as Avandia)
FDA ALERT #1: 5/21/2007, updated 11/19/2007: This update highlights changes to the prescribing information for rosiglitizone including a new BOXED WARNING and changes to the WARNINGS, PRECAUTIONS, and INDICATIONS sections of the label about the potential increased risk of myocardial ischemia. FDA also has requested that the manufacturer, GlaxoSmithKline, develop a Medication Guide for patients that provides information about the safe use of rosiglitazone. Healthcare professionals should factor this new information into their individual treatment decisions for their patients.
FDA ALERT #2: [8/14/2007]: This Alert highlights important revisions to the full prescribing information for rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl). The updated information includes a new BOXED WARNING, and additional updated WARNINGS, PRECAUTIONS and CONTRAINDICATIONS to emphasize that rosiglitazone may cause or exacerbate heart failure, particularly in certain patient populations.
This is a summary of the most important information about Avandia. For details, talk to your healthcare professional.
What is Avandia used for?
Avandia, in addition to diet and exercise, improves blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Avandia can be used alone or in combination with a sulfonylurea, metformin, or insulin. Avandia can also be used in addition to a sulfonylurea plus metformin when diet, exercise, and both agents are not enough to control blood sugar.
Who should not take Avandia?
- Do not use Avandia for type I diabetes (juvenile diabetes) or diabetic ketoacidosis.
- If you have heart failure, fluid retention, or active liver disease your healthcare provider will evaluate you to decide if Avandia is right for you.
General Precautions with Avandia:
- Avandia is in the same class of drugs as Rezulin, which has been associated with rare but serious liver injury, including liver failure leading to transplant or death. Because Avandia’s liver safety profile is not fully determined yet, your doctor will do blood tests that evaluate your liver before starting you on Avandia. These blood tests should be repeated every two months for the first year, then regularly after that.
- Call your healthcare provider right away if you develop nausea, vomiting, stomach pain, a feeling of tiredness or having no energy, loss of appetite, dark urine, or jaundice (yellow coloring of eyes and skin). These may be symptoms of liver problems.
- Patients who experience an unusually rapid increase in weight or retain fluid (edema) or who develop shortness of breath or other symptoms of heart failure while on Avandia should immediately report these symptoms to their healthcare provider.
- Call your doctor if you develop visual symptoms, such as decreased vision or blurry vision, while taking Avandia. Some patients have developed macular edema (a swelling in the back of the eye) while taking Avandia. All patients with diabetes should have eye examinations regularly, no matter what medicine(s) they are taking for diabetes..
- When taking Avandia with other oral diabetes medicines, there is a risk of your blood sugar becoming dangerously low. Ask your healthcare provider about symptoms of low blood sugar, conditions that make low blood sugar more likely, and what to do if you get it. Make sure to explain to family members.
- If you are a woman who has not reached menopause but have not had menstrual periods, you may become pregnant unless you use an effective method of birth control. Avandia, like other drugs in this class, may cause insulin resistant women to start ovulating again.
- Women should tell their doctor if they notice any changes in their monthly menstrual cycle.
- During periods of stress on the body, such as fever, trauma, infection, or surgery, your medication requirements may change; contact your healthcare provider promptly.
Managing your diabetes should include diet control. Caloric restriction, weight loss as needed, and exercise are essential for the proper treatment of diabetes because they help improve insulin sensitivity and the effectiveness of drug therapy.
What should I tell my doctor or healthcare provider?
Tell your healthcare provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.
Because certain other medication may interact with Avandia, review all medications that you are taking with your healthcare provider, including those that you take without a prescription.
What are some possible side effects of Avandia? (This list is NOT a complete list of side effects reported with Avandia. Your healthcare provider can discuss with you a more complete list of side effects.)
- cough or cold
- inflammation of the sinuses
- back pain
- swelling or fluid retention
Information taken from FDA.